Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea

The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.

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Key information

Conditions

Acellular Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Corynebacterium Infections Diphtheria Diphtheria-Tetanus-acellular Pertussis Vaccines Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Picornaviridae Infections Poliomyelitis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Spinal Cord Diseases Tetanus Virus Diseases Whooping Cough

Age range

2 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Seoul, 130-702, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.
Korean male or female subjects who are eligible for the primary and/or booster doses of Infanrix-IPV according to the Korean Prescribing Information.
Written or signed informed consent obtained from the parent(s)/ legally acceptable representative(s) of the child. Where parent(s)/ legally acceptable representatives are illiterate, the consent form will be countersigned by an impartial witness. Prior to enrollment of the subject into the post-marketing surveillance, the subject's parents/legally acceptable representatives will be requested to provide information regarding the enrollment of their child in a same/similar study previously. And prior to obtaining informed consent form, the investigator will check whether the subject is eligible for vaccination.

Exclusion criteria

At the time of post-marketing surveillance (PMS) entry, the contraindications and precautions of use indicated in the local Prescribing Information should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
Subjects who receive any investigational or non-licensed DTPa-IPV vaccine within 30 days prior to study start will not be enrolled.
Child in care.

Treatment and study plan

Infanrix-IPV data collection

Other

Safety monitoring: recording of adverse events using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form.

Primary outcomes

Occurrence of adverse events

Time frame: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.
Occurrence of serious adverse events

Time frame: Starting at Visit 1 in the post-marketing surveillance (PMS) up to 30 days (Day 0 to Day 29) after the last dose is administered in the PMS

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Assessment of Safety of GlaxoSmithKline (GSK) Biologicals' Combined Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus Vaccine, Infanrix-IPV When Administered According to the Approved Prescribing Information in Korea

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Apr 2, 2012
Registry last updated: Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed